A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
NCT ID: NCT06308978
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
244 participants
INTERVENTIONAL
2024-03-28
2042-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Regimen A (Single dose with AMP)
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Regimen B (Single-dose without AMP, with background therapy)
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Regimen C (Two-dose with AMP)
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Regimen D (Two-dose without AMP, with background therapy)
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Regimen B1 (Single-dose without AMP, background therapy temporarily suspended)
FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Interventions
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FT819
FT819 will be administered as intravenous (IV) infusion at planned dose levels.
Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.
* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.
* Health Status: Adequate organ function to tolerate treatment.
* Consent: Able to provide informed consent or assent/obtain parental consent and comply with study procedures.
Exclusion Criteria
* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.
* Active Infections: No recent or ongoing serious infections.
* Recent Cancer or Prior Cell Therapy: No active/recent malignancies, prior CAR T-cell therapy, or organ transplant.
* Allergies: No known allergies to study treatments.
* Weight Restriction: Must weigh at least 50 kg (110 lbs).
12 Years
70 Years
ALL
No
Sponsors
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Fate Therapeutics
INDUSTRY
Responsible Party
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Locations
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Providence Medical Foundation
Fullerton, California, United States
University of California Irvine
Irvine, California, United States
Children's Hospital Los Angeles Division Of Rheumatology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of Minnesota Medical School
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center
New York, New York, United States
Duke University Health System
Durham, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Regional One Health
Memphis, Tennessee, United States
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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FT819-102
Identifier Type: -
Identifier Source: org_study_id